Status:
UNKNOWN
Early Oxybutinin Treatment for Boys With Posterior Urethral Valves
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Male Urogenital Diseases
Eligibility:
MALE
3-6 years
Phase:
PHASE2
Brief Summary
Boys with posterior urethral valves have bladder dysfunction of varying severity. Early treatment of these children with anticholinergics is recommended by some teams, although there have never been a...
Detailed Description
Posterior urethral valves (VUPs) are the leading cause of subvesical obstruction in children with an incidence between 1 / 3,000 to 1 / 8,000 births. 25-45% of patients will have chronic renal failure...
Eligibility Criteria
Inclusion
- Boys
- Aged 3 to 6 months
- Diagnosed with posterior urethral valves, and having undergone valve resection within the first 3 months of life
- Children who have had their valve resection at least 3 months before inclusion
- Having undergone urodynamic studies between 10 weeks and 6 months of age andshowing abnormal urodynamics, notably: high voiding pressure (\>60cm H2O)/ small capacity bladder (\<70% expected bladder volume)and for those without pop-off mechanisms, poor compliance (\<10ml/cmH2O)/
- Holders of parental authority affiliated to French national health insurance
- With informed consent signed by holders of parental authority
Exclusion
- Boys with posterior urethral valves and normal urodynamics or no urodynamic assessment
- Boys in whom urodynamic assessment is not possible for medical or anatomical reasons
- Boys requiring dialysis before the age of 3 months
- Contra-indication to oxybutynin such as hypersensitivity to oxybutynin or any of the excipients, digestive obstruction, occlusive or sub-occlusive syndrome, megacolon, digestive stasis, intestinal atony, paralytic ileus, ulcerative colitis, Hemorrhagic rectocolitis, Crohn's disease, Inflammatory bowel disease, Inflammatory organic colopathy, myasthenia, congenital glaucoma
Key Trial Info
Start Date :
September 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 10 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04526353
Start Date
September 10 2020
End Date
September 10 2023
Last Update
August 25 2020
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